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Mevion Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
3
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0827-2022Class IIMevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)February 1, 2022
Z-0485-2021Class IIMEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver prOctober 19, 2020
Z-2686-2020Class IIMEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patJune 23, 2020
Z-2406-2020Class IIMEVION S250i, MEVION S250; Proton Radiation Treatment SystemMay 15, 2020
Z-0705-2019Class IIMEVION S250iOctober 1, 2018
Z-2746-2018Class IIMEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for theJune 29, 2018
Z-1122-2017Class IIMEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation TherapyDecember 16, 2016
Z-0409-2017Class IIMEVION S250 Product Usage: Proton Radiation TherapyOctober 31, 2016
Z-0410-2017Class IIMEVION S250 Product Usage: Proton Radiation Therapy SystemOctober 21, 2016
Z-0411-2017Class IIMEVION S250 Product Usage: Proton Radiation Therapy SystemOctober 20, 2016
Z-1529-2016Class IIMEVION S250 for Proton Radiation TherapyMarch 15, 2016
Z-0767-2016Class IIMEVION S250 Radiation therapy systemNovember 18, 2015
Z-0588-2015Class IIMEVION S250, used for proton radiation therapy.November 10, 2014
Z-1271-2014Class IIMEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy March 5, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)September 12, 2025
K172848MEVION S250i Proton Beam Radiation Therapy DeviceDecember 27, 2017
K120676S-250 PROTON BEAM RADIATION THERAPY SYSTEMJune 4, 2012